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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dna specimen collection, saliva
Definition A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
Product CodeOYJ
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
ANCESTRY GENOMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DNA GENOTEK INC
  SUBSTANTIALLY EQUIVALENT 1
DNA GENOTEK INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Numbness 2 2
Shaking/Tremors 1 1
Chemical Exposure 1 1
Unspecified Gastrointestinal Problem 1 1
Abdominal Pain 1 1
Arrhythmia 1 1
Dysphagia/ Odynophagia 1 1
Fatigue 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Pain 1 1
Burning Sensation 1 1
Anxiety 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DNA Genotek Inc. II Apr-21-2022
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